FDA NEWS RELEASE

FDA clears first test to diagnose Q fever in military personnel serving overseas

The U.S. Food and Drug Administration today cleared the first nucleic acid amplification test to diagnose the early stages of Q fever infections in military personnel serving overseas. The Chemical Biological Medical System Joint Project Management Office within the U.S. Department of Defense funded the development of this test, which identifies and detects the bacteria that cause Q fever (Coxiella burnetii) within four hours. The test was developed by Idaho Technology Inc.

Q fever is an emerging infectious disease among U.S. soldiers serving in Iraq and worldwide. Q fever can cause acute or chronic illness in humans, who usually acquire infections after contact with infected animals or exposure to contaminated environments.If diagnosed early, most people with Q fever fully recover after treatment with appropriate antibiotics. Failure to treat an infection can, however, result in serious chronic illness.

The FDA cleared this test to be used on the Defense Department’s Joint Biological Agency Identification and Diagnostic System (JBAIDS), a multiple use instrument that can be used for the rapid detection of numerous bacteria and viruses, such as the bacteria that cause Q fever. The test is performed on the JBAIDS instrument and determines if Coxiella burnetii DNA is present in a patient’s blood sample. Use of the test is limited to designated Department of Defense laboratories equipped with the JBAIDS.

“It’s important that the FDA protect our troops from biothreats using innovative diagnostics,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Q fever bacteria is considered a biothreat agent in part due to the fact that fewer than 10 organisms need to be inhaled to cause infection and its ability to withstand open environments.”

According to the U.S. Centers for Disease Control and Prevention, Q fever was first recognized as a human disease in Australia in 1935 and in the United States in the early 1940s. The “Q” stands for “query”—at that time, the causative agent was unknown.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.